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About the Role

The Global Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for Jazz Pharmaceuticals product/s (investigational and marketed) throughout their lifecycle. This includes supporting major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities for specific products. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities.

Responsibilities

Lead the preparation and review of safety-related section(s) for product/s, including clinical, regulatory, and scientific documents.
Serve as the safety representative to a Global Regulatory Team and a Core Development Team.
Interface with Risk Evaluation and Mitigation Strategy (REMS) team to optimize risk management.
Support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation in all Reference Safety Information (RSI).
Support review of medical/scientific literature for signal detection and aggregate reporting.
Support signal detection activities, including identification, evaluation, and validation of safety signals.
Participate in or Lead a Safety Management Team (SMT) for an assigned product.
Contribute to the preparation and review of pre- and post- marketing aggregate safety reports.
Contribute to preparation of Risk Management Plans (RMPs) for assigned products.
Provide guidance with adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data.
Demonstrate or gain knowledge of current and applicable global PV regulations and guidelines.
Provide safety expertise to due diligence activities, if/ as needed.
Keep abreast of new PV/safety regulations and guidance from regulatory authorities.

Requirements

Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered.
Excellent knowledge of drug development process.
Requires a high level of initiative and independence.
Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.
Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word.
Some national/international travel may be required.
Demonstrate collaborative spirit, understanding the benefit of working with others cross functionally, in a dynamic environment.
Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change.
Serve as a positive role model – create followership and effectively mobilize and influence others, both on your teams and across the organization.
Understanding of target product profile; clinical designs and/or global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Clinical and Pharmacovigilance practices (GCP, GVP).
Exposure to working relationship with the FDA, EMA and other regulatory authorities is preferred.
Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems a plus.
MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries a plus.
Ability to manage multiple tasks with deadlines in fast-pace environment.

Skills

Excellent written and oral communication skills
Resourcefulness
Personal organization skills
Cross-functional teamwork
Computer literacy
Proficiency in external Regulatory Databases
Microsoft Excel
Microsoft PowerPoint
Microsoft Word
Understanding of target product profile
Clinical designs
Global PV regulatory environment
International regulations
Initiatives
Standards
Good Clinical Practices (GCP)
Good Pharmacovigilance Practices (GVP)
Working knowledge of safety databases
Electronic data capture systems
MedDRA coding
WHO Drug coding

Location

Remote

Work Type

Full-time

Experience Level

2-5 years

Education Level

MD required
Medical licensure in at least one region preferred
Clinical research training
Fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus

Salary/Compensations

$256,000.00 - $384,000.00

Benefits

Discretionary annual cash bonus or incentive compensation
Discretionary equity grants
Medical insurance
Dental insurance
Vision insurance
401k retirement savings plan
Flexible paid vacation

About the Company

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families.
We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options.
We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.
Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.
Please visit www.jazzpharmaceuticals.com for more information.

Equal Opportunity

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.